Evaluation of Toxicological Profile of a Polyherbal Formulation

In current study toxicological profile of a commonly used herbal formulation was evaluated that is used extensively for gynecological disorders like menorrhagia, metrorrhagia, leucorrhea, irregular menstrual cycle, pre-menstrual syndrome and post-menopausal bleeding. It was also claimed to strengthen endometrium and ovaries. Since this herbal formulation was been used by a large number of population hence there was a need to assess acute and sub-chronic toxicity. Acute oral toxicity (LD50) was observed in albino mice using standard protocols whereas sub-chronic, hematological and histopathological studies were assessed on 24 albino rabbits after giving herbal formulation for 60 days in two doses (20 and 60 mg/kg) against control groups. The outcomes of present study showed that the drug is safe up to 5000 mg/kg following acute oral toxicity test and no mortality was observed during sub chronic toxicity studies. Results of sub-chronic toxicity did not show any significant changes in biochemical, hematological and histopathological parameters. However, some indicators such as urea, creatinine, hemoglobin, and RBC count were altered, but these changes do not correlate with the histopathological results and may be associated to intra individual variations. Despite the safety of the drug in few animals, clinical trials and more investigations on a large number of animals are essentially needed to establish safety and efficacy of the herbal formulation.